Ironwood's IW-3718 meets primary in Phase IIb to treat GERD

Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) said top-line data from a double-blind, U.S. Phase IIb trial in 282 patients with uncontrolled gastroesophageal reflux disease (GERD) showed that twice-daily 1,500 mg oral IW-3718 plus a proton pump inhibitor (PPI) for 8 weeks met the primary endpoint of reducing mean weekly heartburn severity from baseline vs. a PPI alone (58% vs. 46%, p=0.04). Patients received PPI monotherapy or twice-daily 500; 1,000; or 1,500 mg oral IW-3718 plus a PPI.

High-dose IW-3718 plus a PPI also met the secondary endpoint of reducing weekly regurgitation frequency vs. PPI monotherapy (55.4% vs. 37.9%, p=0.01). The combo led to a rate of heartburn response, a secondary endpoint, of 52.9% 37.1% vs. for a PPI alone. Heartburn response was defined as a 45% reduction from baseline in weekly heartburn severity for ≥4 of 8 weeks, including ≥1 of the last 2 weeks. Other secondary endpoints include percent change from baseline to 4 weeks in weekly heartburn severity and proportion of heartburn-free days...